PMO-169 Pegylated interferon α, Nitazoxanide, Telapravir, Ribavirin, in genotype 1 undergoing prior experienced chronic hepatitis C patients: a randomised placebo control clinical pilot trial (I N T R I G U E C) interim

IntroductionChronic hepatitis C is a global challenge with end stage liver disease and rising Hepatocellular Carcinoma. Peg Interferon α and Ribavirin was the backbone of therapy. Recently introduced Directly Acting Antivirals -protease inhibitor has a promising role in escalating Sustained Viral Response in Response guided therapy in non-responders, partial and relapses. This study utilised Nitazoxanide (NTZ) and Telapravir, with SOC for 24 weeks in treatment experienced patients.Methods50 (n=50) patients were divided into Group A (n=12) NTZ 500 mg three times for 12 weeks, Group B (n=12) NTZ 500 mg twice daily for 24 weeks Group C (n=26) control. All received Peg Interferon α 2a 180 μg SQ QOW with fixed dose of Ribavirin 1200 mg daily for 24 weeks with Telapravir 750 mg three times daily for 12 weeks. Viral load was obtained at day 0, 7th day, 14th day, 4 weeks, 12th week and 24 weeks. Viral kinetics was analysed. In Group A: 5/12 (42%) Non-Responder, 6/12 (50%) partial responder, 2/12 (16%) relapsers. In Group B: 5/12 (42%) Non-responders, 6/12 (50%) partial responder, 1/12 relapsers (8%). In Group C: 10/26 (38%) non-responder, 10/26 (38%) partial responder, 4/26 (15%) relapsers, 2/26 (8%) unknown. Exclusion: Decompensated Cirrhotic, HCC, poor DM, Haemolytic Anaemia, Severe Coronary artery disease, major depression, renal failure, Prior severe skin rash, active drug and alcohol abuse. Side Effects: Anaemia 28/50 (56%), Neutropenia 14/50 (28%), Thrombocytopaenia 8/50 (16%), Fatigue 34/50 (68%), Depression 10/50 (20%), Mild skin rash 22/50 (44%), Severe skin rash 1/50 (2%). Use of Growth factors: Epogen 12/50 (24%) Neupogen 8/50 (16%) Elthrombopag 5/50 (10%).ResultsResultsGroup AGroup BGroup CUndetectable9/12 (75%)10/12 (83%)16/26 (62%)NR1/12 (8%)2/12 (16%)4/26 (15%)PR1/12 (8%)12/12 (100%)3/26 (11%)AVR11/12 (92%)12/12 (100%)20/26 (77%)VRVR11/12 (92%)10/12 (83%)22/26 (84%)RVR9/12 (75%)10/12 (83%)18/26 (70%)EVR9/12 (75%)10/12 (83%)16/26 (62%)ETVR9/12 (75%)10/12 (83%)16/26 (62%)ConclusionThis quadruple truncated regimen has excelled the RVR, ETVR over SOC with Directly Acting Antivirals over 13%, without any difference between 24 weeks of NTZ over 12. Needs a larger trial for validation.Competing interestsNone declared.